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Recruiting NCT05390567

Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women

Conditions: Cervical Cancer Screening Methods

Sex: Female
Ages: 25 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 800
Sponsor: University of Florida

Location: University of Florida Gainesville Florida

Summary

Project CONTINUITY (Connecting You to Care in the Community) was developed to increase adherence to cervical cancer screening regimens from initial screening to needed follow-up care by (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method (Pap/HPV co-testing vs. HPV self-test collection), community clinical navigators and community health workers (CHWs), customized messages and support for patient portal access for test results and (2) implementing strategies to address social determinants of health (SDoH) that may influence an individual's ability to adhere to the screening regimen, with an initial focus on removing transportation barriers through the use of a mobile outreach clinics (MOC).

Eligibility Criteria

Inclusion Criteria: 1. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible. 2. Assigned sex at birth is female 3. No previous history of cervical cancer 4. No previous history of a hysterectomy 5. Not currently pregnant (self-report) 6. Not currently menstruating\* 7. Have not used any vaginal products (e.g., oil-based lubricants, antifungal, and douches) in prior 2 days\*. Use of vaginal contraceptives, condoms and water-based lubricants are allowed. 8. Have not given birth in the prior 12 weeks\* 9. Self-report they have not undergone cancer screening in the past 4 years or more OR report being past due according to provider recommended screening schedule. 10. Self-report of using the MOC in the past, no current usual source of care OR usual source of care is a non-UFH provider and/or cervical cancer screening is not accessible through that provider 11. Reside in census tracts where the Mobile Outreach Clinic travels. 12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address. Exclusion Criteria: * For patients who are excluded for criterion 6, 7, and 8, the outreach team (community clinical navigator and CHW) will ask the participant if they can be re-contacted for potential future study eligibility assessment. If the participant agrees, the navigator or CHW will collect contact information to re-contact the participant at a later (pre-determined) date up to 20 weeks later for eligibility screening.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05390567). StuddyBuddy aggregates publicly available trial information.